MAUDE Adverse Event Report: PENUMBRA, INC. LIGHTNING 8 INDIGO SYSTEM; QEW

Model Number	LITNG8XTORQ115-S
Medical Device Problem Codes	Misconnection (1399); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat pulmonary embolism using the lightning aspiration tubing (lightning) and an indigo system aspiration catheter 12 (cat12).During the procedure, the rotating hemostasis valve (rhv) was unscrewed and would not screw back.Therefore, the rhv was removed.The procedure was completed using a new rhv with the same cat12 and lightning.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report: 1.Section b.Box 5.Describe event or problem h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat pulmonary embolism using the lightning aspiration tubing (lightning) and an indigo system aspiration catheter 8 (cat8).During the procedure, the rotating hemostasis valve (rhv) was unscrewed and would not screw back.Therefore, the rhv was removed.The procedure was completed using a new rhv with the same cat12 and lightning.There was no report of an adverse effect to the patient.

• Brand Name: LIGHTNING 8 INDIGO SYSTEM
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12627589
• Report Number: 3005168196-2021-02279
• Device Sequence Number: 11123504
• Product Code: QEW
• UDI-Device Identifier: 00815948023291
• UDI-Public: 00815948023291
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2022
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: LITNG8XTORQ115-S
• Device Catalogue Number: LITNG8XTORQ115
• Device Lot Number: H11218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 05/06/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005